This section provides background information related to the present disclosure which is not necessarily prior art.
A voice prosthesis is a one-way valve placed into a puncture between the trachea and the esophagus of a user who cannot speak following total laryngectomy, or surgical removal of the larynx (voice box). The voice prosthesis allows air to flow from the lungs through the trachea and into the esophagus to enable tracheoesophageal voice/speech. Flanges at both ends of the voice prosthesis retain the prosthesis in the tracheoesophageal puncture. Prior to voice prosthesis insertion, a dilator has been used to prevent the puncture from closing, eliminate leakage of the esophageal content and to dilate the puncture prior to initial insertion and later re-insertion of the voice prosthesis. An exemplary known dilator device is a BLOM-SINGER® tracheoesophageal puncture dilator available from InHealth Technologies, a division of Helix Medical, LLC.
After removal of a surgical catheter or voice prosthesis, the dilator maintains the open fistula. Once inserted, the dilator is taped in place on the neck. This device is then removed after several minutes of dilation. Once the fistula is dilated, it needs to be sized. A voice prosthesis sizer, such as the BLOM-SINGER® voice prosthesis sizer available from InHealth Technologies, a division of Helix Medical, LLC, is placed on an inserter and the device is inserted into the fistula. The sizer is gently withdrawn until resistance is detected indicating that the esophageal collar is seated against the interior wall of the esophagus. The size is then read at the mark closest to the puncture entrance. After sizing, a voice prosthesis is then inserted into the puncture for voicing.
U.S. Pat. No. 7,975,696, assigned to an assignee of the present application, is directed to a voice prosthesis dilator and sizer device that combines the functions of the separate voice prosthesis dilator and the sizer into a single device in order to provide a dilating and sizing function that is gentler on the fistula in that only one insertion is needed rather than two. The voice prosthesis dilator and sizer device is used by a clinician for replacing an existing voice prosthesis in an existing tracheoesophageal puncture.
It is desirable to provide a catheter device and delivery method that is intended for use in surgical procedures wherein the primary (during total laryngectomy) or secondary tracheoesophageal puncture is formed, and wherein the catheter can be used for dilation, selection of proper length voice prosthesis, and placement of a voice prosthesis during the surgical procedure while a patient is typically sedated.